Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: MONDAY, January 13, 1992 TAG: 9201130095
SECTION: NATIONAL/INTERNATIONAL PAGE: A1 EDITION: METRO
SOURCE: The New York Times
DATELINE: WASHINGTON LENGTH: Medium
IMPLANT TESTING STALLED
Scientists within Dow Corning Co. urged company officials for years to conduct critical safety studies of its silicone-gel breast implants, but the tests were put off for more than a decade, a review of hundreds of company documents shows.The documents, made available to The New York Times from several sources, also suggest that the studies that were done were inadequate. They describe insertion of implants into women before they had been tested in animals, and suggest that Dow Corning Wright breast implants may have been tested in animals but not in animal breast tissue.
In 1976, 16 months after a new implant was put on the market, an official in charge of its development was still expressing frustration over the lack of data about it.
"We are engulfed in unqualified speculation," wrote A.H. Rathjen, who led a task force working on the implant. "Nothing to date is truly quantitative. Is there something in the implant that migrates out or off the mammary prosthesis? Yes or no! Does it continue for the life of the implant or is it limited or controlled for a period of time? What is it?"
Officials of Dow Corning, the leading maker of implants, maintain that they are safe, that most women who have them are delighted with them and that the memorandums challenging company practices paint an inaccurate and incomplete picture. But critics challenge that view.
"Dow Corning and the plastic surgeons have conducted a massive experiment on women, under the guise of selling a commercial product," said Thomas Talcott, who quit Dow Corning in 1976 in what he said was a protest of its safety practices. Talcott, an engineer, was the head of the company's technical services and development group, which was responsible for testing the implant components.
The Food and Drug Administration last week called for a moratorium on the devices pending a review of safety data. An agency panel will meet Feb. 11 to consider the matter.
"We cannot assure the safety of this product," FDA Commissioner David Kessler said.
To Dr. Norman Anderson of Johns Hopkins University, who has been a consultant to the FDA on the issue, the lack of directly relevant scientific studies is astonishing.
In a letter sent to Kessler three days ago, he noted he had reviewed all of Dow Corning's submissions to the FDA and found that none of the studies in animals put silicone or implants in or under breast tissue, as is done with women.
"Although I am only a clinician, I find this omission a peculiar phenomenon which must be unprecedented in the history of medical device evaluation," he said.
But the chief of health care at Dow Corning, Robert T. Rylee, said the implants have been adequately tested and shown to be safe.
But he conceded that the company probably should have carried out some studies it did not.